Phase 1
Completed N=12
Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.
Healthy
Source: ClinicalTrials.gov NCT04973826 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Aztreonam — 69.44; 79.66 micrograms per milliliter (ug/mL)
Summary
A Phase 1, single center, single arm, open-label study to assess the PK, safety and tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy Chinese participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Aztreonam |
69.44; 79.66 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) on Day 1 & 4 of Avibactam |
13.93; 14.03 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Aztreonam |
236.7 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 to 6 Hours (AUC6) on Day 1 of Avibactam |
42.36 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Aztreonam |
287.8; 336.4 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) on Day 1 & 4 of Avibactam |
47.23; 49.47 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Aztreonam |
289.6; 337.5 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) on Day 1 & 4 of Avibactam |
47.33; 49.47 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Aztreonam |
289.2; 337.6 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) on Day 1 & 4 of Avibactam |
47.29; 49.59 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Aztreonam |
285.2 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the End of the Dosing Interval (τ), Where τ=6 Hours (AUCtau) on Day 4 of Avibactam |
44.41 | — |
| PRIMARY Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Aztreonam |
1142 | — |
| PRIMARY Total Daily Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours at Steady-State (AUC24,ss) on Day 4 of Avibactam |
177.7 | — |
| PRIMARY Renal Clearance (CLr) on Day 1 & 4 of Aztreonam |
4.277; 4.487 | — |
| PRIMARY Renal Clearance (CLr) on Day 1 & 4 of Avibactam |
12.09; 12.65 | — |
| SECONDARY Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Aztreonam |
1.890; 1.886 | — |
| SECONDARY Terminal Elimination Half-Life (T1/2) on Day 1 & 4 of Avibactam |
2.003; 4.061 | — |
| SECONDARY Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Aztreonam |
13.69; 12.81 | — |
| SECONDARY Apparent Volume of Distribution at Steady-State (Vss) on Day 1 & 4 of Avibactam |
21.36; 17.96 | — |
| SECONDARY Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Aztreonam |
14.09; 14.22 | — |
| SECONDARY Apparent Volume of Distribution During Terminal Phase (Vz) on Day 1 & 4 of Avibactam |
30.14; 65.41 | — |
| SECONDARY Clearance (CL) on Day 1 & 4 of Aztreonam |
5.188; 5.261 | — |
| SECONDARY Clearance (CL) on Day 1 & 4 of Avibactam |
10.56; 11.26 | — |
| SECONDARY Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Aztreonam |
2.92; 2.92 | — |
| SECONDARY Time of Observed Maximum Plasma Concentration (Tmax) on Day 1 & 4 of Avibactam |
2.44; 2.46 | — |
| SECONDARY Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Aztreonam |
1.149 | — |
| SECONDARY Accumulation Ratio for Cmax (Rac,Cmax) on Day 4 of Avibactam |
1.006 | — |
| SECONDARY Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Aztreonam |
1.204 | — |
| SECONDARY Accumulation Ratio for AUCτ Following Multiple Dosing (Rac) on Day 4 of Avibactam |
1.049 | — |
| SECONDARY Number of Participants With an Adverse Event (AE) |
2; 1 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiograms (ECGs) |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Assessments |
1; 1; 3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy Chinese male and female participants
- No clinical relevant abnormalities
- willing and able to comply with all study procedures
- BMI:17.5-30.5
- Sign informed consent
Exclusion Criteria
- Any clinical significant illness
- History of alcohol abuse
- Use within 14 days prior the first study dose
- CL>80ml/min
- Abnormal vital signs, such 12-ECG, blood pressure and pulse rate
- Blood donation within 60days
- History of HIV, HBsAg, HBcAb, HCVAb
- Other medical or psychiatric may inappropriate for the study
Data sourced from ClinicalTrials.gov (NCT04973826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.